Dermatologists welcome PBS listing of first-in-class psoriasis therapy with superior efficacy

Pharma News: In a significant development for patients with severe chronic plaque psoriasis, Bristol Myers Squibb’s first-in-class, oral tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib), has earned its place on the Pharmaceutical Benefits Scheme (PBS) as of October 1, 2023.

This milestone comes on the heels of two pivotal Phase 3 clinical trials (POETYK PSO-1 and POETYK PSO-2) where Sotyktu showcased superior efficacy when compared to a placebo and Amgen’s twice-daily Otezla (apremilast). The heightened efficacy was pronounced at both 16 and 24 weeks, with patients maintaining a positive response to the treatment even through the 52-week mark.

BMS’ decision to sell Otezla to Amgen was strategic, aimed at facilitating regulatory clearance for the Celgene merger in 2019. This move reflected their belief in the potential of the then-investigational Sotyktu to outperform its established oral predecessor in plaque psoriasis treatment.

Associate Professor Peter Foley, Head of Dermatology Research at St Vincent’s Hospital, Melbourne, and Director of Research at Skin Health Institute, Melbourne, emphasised the transformative nature of this PBS listing. He highlighted how it represents a fresh approach to addressing the chronic, immune-mediated nature of plaque psoriasis, which often necessitates prolonged, tailored treatments to effectively manage symptoms and prevent relapses.

“Unfortunately, plaque psoriasis can be under-treated, and even untreated. A significant portion of patients may not be presenting to their GPs because they are not aware of new therapy options,” said A/Professor Foley.

“The reimbursement of this first-in-class therapy option for Australians living with severe chronic plaque psoriasis represents a major milestone in helping to address the substantial, unmet, clinical need for these patients.”

Adding to this perspective, Professor Stephen Shumack, OAM, Clinical Associate Professor at the University of Sydney (USYD), Sydney Medical School (Northern), and Senior Staff Specialist at the Royal North Shore Hospital (RNSH), stressed the chronic impact on physical health and overall wellbeing.

Severe forms of the disease are associated with increased risk of comorbidities, including inflammatory bowel disease (IBD) and cardiovascular disease, and may lead to the development of joint inflammation, and subsequent psoriatic arthritis.

“Plaque psoriasis is the most common form of psoriasis, accounting for approximately 90 per cent of all psoriasis cases,” Professor Shumack said.

Dr Melinda Munns, Medical Director for BMS in Australia and New Zealand, further emphasised the paramount importance of improving patient access to affordable treatment options.

“Psoriasis is a chronic, lifelong disease imposing a substantial physical and mental burden on patients. Severe plaque psoriasis can significantly reduce overall quality of life, and can compromise relationships, career, social activities, and emotional wellbeing,” she commented.

“The reimbursement of Sotyktu is a positive step toward improving affordable treatment access for Australians living with this disease,” said Dr Munns.

Earlier this year, Takeda revealed data from the 12-week phase 2 clinical trial of oral TAK-279 showing that 68% and 67% of patients at the middle and high dose level had a 75% resolution of their symptoms, as measured by the Psoriasis Area and Severity Index (PASI). The PASI 75 rate in the placebo group was 6%. The difference in PASI 75 was enough for the study to hit its primary endpoint and suggest that the drug candidate may have an edge over BMS’ Sotyktu. First, though, Takeda will have to replicate these findings in a phase 3 clinical trial. 

Earlier this year, Takeda unveiled the findings from a 12-week Phase 2b clinical trial involving oral TAK-279 in plaque psoriasis. The data revealed a 68% and 67% of patients at the middle and high dose levels experiencing a 75% improvement in symptoms, as assessed by the Psoriasis Area and Severity Index (PASI). In contrast, the PASI 75 rate for the placebo group barely nudged at 6%. The difference was enough for the study to hit its primary endpoint and suggest that the drug candidate may have an edge over BMS’ Sotyktu. However, the ultimate challenge lies ahead as Takeda prepares to validate these findings in a Phase 3 clinical trial.

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